Safety Study of Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS)

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

March 31, 2015

Study Completion Date

April 30, 2015

Conditions
Complication of Transplanted Lung
Interventions
DRUG

Aztreonam Lysine for Inhalation (AZLI)

The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)

PROCEDURE

Status Post Lung Transplant

Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care.

Trial Locations (2)

27710

Duke University Medical Center, Durham

90095

David Geffen School of Medicine at UCLA, Los Angeles

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

Duke University

OTHER